The United States Food and Drug Administration (FDA) has issued a second response letter to Merck & Co, Inc. in regards to their supplemental biologics license application (sBLA) for use of Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] for women ages 27 to 45.
The FDA cites that Merck needs to submit additional data for the sBLA once the four-year study is completed.
The complete response letter does not affect the sBLA submitted for Gardasil in males or its current indication for females ages 9 to 26.
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